The present invention relates to nutritional supplements to be administered to, or to be taken by, women desiring to become pregnant, and pregnant and nursing women. Increased incidence of birth defects (e.g., neural tube defects) has been linked to mothers with various nutritional deficiencies. It is known that there are numerous deficiencies in the diets of pregnant and nursing women, particularly, but not exclusively, women of low and moderate incomes. More broadly, diets of people in general, and women in particular, in the United States are known to be poor, due in part to the prevalence of so-called “junk food”, fast food, which is high in caloric content, but low in nutritional value, and the desire of many working people to eat prepared food after a long day at the office. One example of this is witnessed in the high-omega-6/omega-3 fatty acid ratio (some studies have documented ratios of nearly 17 to 1) seen in the Western diet. In addition, many commonly prescribed medications cause nutrient depletion. The widely used anti-diabetic drug metformin, for instance, has been shown to reduce folate, magnesium, and Vitamin B12 levels. Furthermore, individuals may possess genetic polymorphisms that diminish their ability to metabolize dietary nutrients. For example, patients with defective intestinal conjugase activity may not be able to effectively metabolize natural folates, which exist in the polyglutamate form. For women of child-bearing age, the situation becomes worse when they become pregnant and thereafter during pregnancy as what the fetus needs may not be provided by a given woman's normal daily dietary intake. Another obstacle to achieving a healthful, proper pregnancy diet is the nausea experienced during the early part of pregnancy.
Many supplements have been proposed and are currently being marketed in the United States to overcome the nutritional deficiencies caused by such eating habits. For example, Hermelin et al. in U.S. Pat. Nos. 6,258,466, 6,576,666 and 7,112,609 describe in the Background of the Invention sections of their respective inventions, various formulations and supplements, including prenatal formulations and supplements, that are (or were) on the market in the United States and contain various combinations of ingredients to supplement the nutrition, among others, of pregnant and nursing women. Such products are known by the names Materna, Enfamil, Natalins RX, Prenate Ultra, Niferex-PN, Niferex-PN Forte, Advanced Formula Zenate, Precare, and Natafort, all marketed by various companies that own the trademarked names of these products. See also Meyrowitz U.S. Pat. No. 7,238,373, Giordano et al. U.S. Pat. Nos. 7,390,509 and 7,560,123, Lane U.S. Pat. No. 7,572,462, Morrison et al. U.S. Pat. No. 7,964,189 and U.S. Pat. No. 8,454,951, and Nidamarty et al. U.S. Pat. No. 7,994,217.
Many of the supplements described above, and elsewhere in the literature, including those supplements currently on the market in the United States, contain a broad range of ingredients, many of which are not necessary to be administered to pregnant or nursing women. Some of these ingredients, while generally safe, may not be optimal choices for certain populations. Heme iron, for example while highly bioavailable, is not always the best option for prenatal iron supplementation. However, commonly used forms of non-heme iron cause gastrointestinal distress, which undermines individual or patient compliance. While ingredients used in currently available supplements may not do any harm, in the sense that the body will eliminate in one way or another that which is not needed, there is a preference, and it is our desire, to set forth unique supplement formulations that have those, and only those, ingredients that serve necessary and beneficial purposes, particularly for pregnant and nursing women, or women desiring to become pregnant.